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This section describes how to abstract and edit the scientific details of clinical trials.

About Scientific Data

You can edit or add most trial-related scientific information except codes and other identifiers that the system generates, such as the NCI Trial Identifier. Scientific information for trials comprises the following:
  • Trial descriptions
  • Trial design, including design details, outcome measures, and eligibility criteria
  • Diseases and conditions
  • Data Table 4 anatomic sites
  • Biomarkers (Markers)
  • Interventions
  • Arms for Interventional trials
  • Groups and cohorts for Non-interventional trials
  • Sub-groups

After a trial has been accepted, if you log in with an appropriate role, the Scientific Data menu contains an option for each of the above categories.

The trial summary remains displayed at the top of each page as you navigate through the Scientific Data section.

When you have completed abstracting all trial information on a given page, be sure to click the Save button at the bottom of each page before you proceed to another task.

Abstracting Trial Descriptions

Trial descriptions include the following information:
  • Brief title
  • Brief summary

Additionally, they may include a detailed description.

How to Abstract Trial Descriptions

  1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

  2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

  3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)

  4. On the Scientific Data menu, click Trial Description. The Trial Description page appears.
    Trial Description page

  5. On Trial Description page, in the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

    You can expand text fields and table cells to reveal all of their content

    To increase the size of a text field or table cell, click and drag the lower right corner handle.

    Sizing handle at the lower right corner of a text field

    Sizing handle at the lower right corner of a table cell

    Trial Description

    Instruction

    Brief Title*

    Enter a title that summarizes the purpose of the trial.

    Brief Summary*

    Enter a summary description of the trial.

    Detailed Description

    Optionally, enter all the information that accurately describes the trial in detail.

  6. Click Save.

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Abstracting Interventional Trial Design

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Abstracting Non-Interventional Trial Design

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Abstracting Outcomes

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Abstracting Eligibility Criteria

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Abstracting Diseases and Conditions 

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Abstracting Data Table 4 Anatomic Sites

You can select and record anatomic site terms that identify the anatomic cancer site(s) on which a trial or study is focused. These records are included in a Data Table 4 report. A trial can have multiple anatomic sites.

For instructions, refer to the following pages:

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Abstracting Biomarkers

The abstraction of biomarkers applies to Complete and Abbreviated trial categories. You can record biomarkers, their classification, and purpose. Biomarkers for a given study may be available from the study protocol documents. You can search caDSR for biomarkers. If you do not find the biomarker in the caDSR, you can create a placeholder entry for the biomarker named in the protocol.

For instructions, refer to the following pages:

Abstracting Interventions

You can search for, and select, interventions from a stored list of active intervention terms extracted from NCIt and link them to a trial. NCIt is an online database developed and maintained by the National Cancer Institute Enterprise Vocabulary Services. You can find more detailed information about NCIt at http://ncit.nci.nih.gov/.

Additionally, Protocol Abstraction provides a structure for describing drug, radiation, and surgical procedure details. It generates a description from values you provide for such parameters as dose, target site, frequency of administration, etc.

Obsolete terms

Some intervention terms become obsolete over time. When you validate the trial, the system displays an error message if the abstraction contains an obsolete term. If this occurs, look up the intervention name and replace the obsolete term with the new one.

Trials can have multiple intervention records. Each record displays the following information about the intervention:

Intervention data definitions

Column Name

Definition

Name

Standard name used to refer to each intervention. For drugs, this is the generic name. For investigational new drugs that do not yet have a generic name, this may be the chemical name, company code, or serial number.

Other Names

Synonym or other name 1

Description

For drug interventions, a summary of the drug’s chemical nature and (potential) mechanism of action, and/or details such as dosage form, dosage, frequency, and duration.
For other interventions, a summary of the procedure or device that provides key details that distinguish it from similar interventions.

Tip

You can generate descriptions for drug, radiation, and surgical procedure interventions using Protocol Abstraction’s structured approach. To do so, see Generating Drug, Radiation, and Procedure/Surgery Descriptions.

Type

Mode of intervention, for example, drug or device.

  1. Alternate names you record appear in the TSR and XML documents. ↩

Additionally, you can add, edit, reorder, and delete records.

Sorting intervention records

You can change the sort order (ascending/descending) of any column other than Edit and Delete by clicking the column name and selecting the up or down arrow that appears.

 

Interventions page

For instructions, refer to the following pages:

Abstracting Arms 

In interventional studies, an arm is a group of study subjects associated with a given treatment assignment. Arm information is required for Complete trials, and is optional for Abbreviated trials. 

When adding arms to a trial, you assign to them the interventions currently abstracted for the trial. For instructions on abstracting interventions, refer to Abstracting Interventions.

The following rules apply to each trial: 

  • There must be at least one arm/group that implies that the entire study subject population receives the same intervention.

  • The number of arms/groups added to the trial must coincide with the number indicated in the trial’s Design Details. See Abstracting Interventional Trial Design Details.

  • Every arm must have at least one assigned intervention (except for the arm type "no intervention").
  • Every intervention must be assigned to at least one arm.
  • There must be only one arm with the same combination of description and associated intervention.
  • Arm details for single-arm trials are not required.

Trials can have multiple arm records. Each record displays the following arm information:

Field

Definition

Label

Short name used to identify the arm or comparison group.

Type

Function of the arm. Valid types are as follows:

  • Experimental. An arm or group in which an experimental drug or regimen is being administered. Used when the trial specifies that one arm is a control arm and the other is experimental, or when the other arm is a placebo arm.
  • Active Comparator. An arm or group in which active drugs are given. Includes arms that are mixing active drugs and placebos. Used when the term “control arm” is specified in the protocol and when another arm is designated as the experimental arm. There can be more than one active comparator arm.
  • Placebo Comparator. An arm or group in which only a placebo is given.
  • Sham Comparator. An arm or group in which only a mock therapy that is not a drug is administered
  • No intervention. An observational arm or group
  • Other. An arm or group which does not fall into any of the above categories.

Description

Brief description of the arm or comparison group to distinguish it from other arms/groups in the trial.

Assigned Interventions

Intervention(s) assigned to a given arm. 1

____

  1. Interventions imported from ClinicalTrials.gov may not match CTRP terminology. ↩

Arms page

For instructions, refer to the following pages:

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Abstracting Groups and Cohorts

Group/cohort information pertains to Complete non-interventional trials only. In non-interventional studies, cohorts are groups of individuals, initially defined and composed, with common characteristics (e.g., condition, birth year), who are examined or traced over a given time period.

When adding groups to a trial, you assign to them the interventions currently abstracted for the trial.

Check out the trial before you begin abstraction

Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data.

The following rules apply to each trial:

  • There must be at least one group/cohort that implies that the entire study subject population receives the same intervention.

  • The number of groups/cohorts added to the trial must coincide with the number indicated in the trial’s Design Details. See Abstracting Non-Interventional Trial Design Details .

  • Every group/cohort must have at least one assigned intervention.
  • Every intervention must be assigned to at least one group/cohort.
  • A trial must have only one group with the same combination of description and associated intervention.

Trials can have multiple group/cohort records. Each record displays the following group information:

Field

Definition

Label

Short name used to identify the group

Description

Explanation of the nature of the study group (e.g., those with a condition and those without a condition; those with an exposure and those without an exposure).

Assigned Interventions

Intervention assigned to a given group

 Groups page annotated to indicate features
Group Records

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Adding Groups

You can add one or more groups to a trial according to the number specified in the trial’s design details. See Abstracting Non-Interventional Trial Design Details .

How to Add Groups

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Scientific Data menu, click Groups/Cohorts. The Groups page appears, with or without any group records displayed.
  3. Click Add. The Add Group page appears. The interventions that have been abstracted previously are displayed on the right side of the page.

    Add Group page with an intervention available for assignment

  4. In the check boxes and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

    You can expand text fields and table cells to reveal all of their content

    To increase the size of a text field or table cell, click and drag the lower right corner handle.

    Sizing handle at the lower right corner of a text field

    Sizing handle at the lower right corner of a table cell

    Field

    Instruction/Description

    Label*

    Enter the descriptive name of the group.

    Description*

    Enter a brief description of the group.

    Assignment

    Select the check box(s) in the column for the intervention(s) assigned to the current group.

  5. Repeat the steps above until all groups have been assigned an intervention and all interventions have been assigned to at least one group.
  6. Click Save.

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Editing Groups

You can edit group records as necessary.

How to Edit Group Records

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Scientific Data menu, click Groups/Cohorts. The Groups page appears.
  3. In the Edit column for a given record, click the Edit icon.
    The Edit Group page appears.
    Edit Group page
  4. Make changes as necessary to the Label, Description, or Intervention Assignment according to instructions in Adding Groups.

    You can expand text fields and table cells to reveal all of their content

    To increase the size of a text field or table cell, click and drag the lower right corner handle.

    Sizing handle at the lower right corner of a text field

    Sizing handle at the lower right corner of a table cell

  5. Click Save.

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Deleting Groups

When you delete groups from a trial, you delete them from the system, and can not recover them. If you delete a record accidentally, follow the instructions in Adding Groups to add it back.

How to Delete Groups

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Scientific Data menu, click Groups/Cohorts. The Groups page appears.
  3. In the Delete column, select the check box for the appropriate record(s), and then click Delete.
  4. To delete all groups, click Select All, and then click Delete.

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Abstracting Sub-Groups

A sub-group represents stratification criteria that can be used to assign patients to study arms and assess study outcomes. Sub-group information is required for Complete trials only, and optional for Abbreviated trials.

Trials can have multiple sub-group records. Each record displays the following information about the disease or conditions:

Field

Definition

Code

Characters, or phrase used to identify the sub-group

Description

Stratification criteria

Check out the trial before you begin abstraction

Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data.


Sub-groups Information page
Sub-Groups Page

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Adding Subgroups

You can add one or more sub-groups to a trial according to the trial’s design details.

How to Add Sub-groups

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Scientific Data menu, click Sub-groups. The Sub-groups page appears, with or without any sub-group records displayed.
  3. Click Add. The Add/Edit Sub-group Information page appears.
    Add Edit Sub-group Information page
  4. In the Code field, enter a unique sub-group identifier.
  5. In the Description field, enter a brief description of the sub-group.
  6. Click Save.
  7. Repeat the steps above until all sub-groups have been added.

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Editing Subgroups

You can edit sub-group records as necessary.

How to Edit Sub-group Records

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Scientific Data menu, click Sub-groups. The Sub-groups page appears.
  3. In the Edit column for a given record, click the Edit icon. The Add/Edit Sub-group Information page appears.
  4. Modify the sub-group details according to instructions in Adding Sub-Groups.
  5. Click Save.

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Deleting Subgroups

When you delete groups from a trial, you delete them from the system, and can not recover them. If you delete a record accidentally, follow the instructions in Adding Sub-Groups to add it back.

How to Delete Sub-groups

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. On the Scientific Data menu, click Sub-groups. The Sub-group page appears.
  3. In the Delete column for the appropriate record, click the Delete icon.

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